SINGLE USE MANUAL RESUSCITATORS— 510(k) K905002

Name: FDA 510(k) clearance K905002
Creator: U.S. Food and Drug Administration
Published: 1991-03-29

Substantially Equivalent

Custom Medical, Inc.

FDA 510(k) clearance K905002 for SINGLE USE MANUAL RESUSCITATORS, Substantially Equivalent on 1991-03-29. Applicant: Custom Medical, Inc.. Device class: 2.

Clearance details

Applicant: Custom Medical, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1990-11-07
Decision date: 1991-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTM

view all

K251631 — The BAG manual resuscitator and accessories2025-11-24
K243861 — butterflyBVM2025-04-25
K221841 — EOlife®2023-03-18
K212905 — Sotair Device2022-08-18
K210288 — Disposable Manual Resuscitator2021-08-26

More clearances from Custom Medical, Inc.

view all

K832758 — RED COLOR-TINTED TUBING1983-09-12
K830182 — CUSTOM IV SET1983-05-09

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.